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U.S. Department of Health and Human Services

Class 2 Device Recall XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM

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 Class 2 Device Recall XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MMsee related information
Date Initiated by FirmAugust 19, 2026
Date PostedSeptember 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3183-2026
Recall Event ID 99634
510(K)NumberK201511 
Product Classification Laparoscope, general & plastic surgery, reprocessed - Product Code NLM
ProductREF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM
Code Information UDI: (01)00885825017231/ Lots: 16188647 16210212 16243934 16267300 16285639 16285656 16306188 16306231 16364978 16470903 16521533 16547722 16580202 16599810 16637989 16656930 16665550 17005619 17069758 17113276 17117460 17146892 17172722 17389157
FEI Number 3009350690
Recalling Firm/
Manufacturer		 Stryker Sustainability Solutions
1810 W Drake Dr
Tempe AZ 85283-4327
For Additional Information ContactStryker Customer Service
800-624-4422
Manufacturer Reason
for Recall		Reusable access port system may crack or seperate during use.
FDA Determined
Cause 2		Device Design
ActionOn August 19, 2026, Stryker Sustainability Solutions (SSS)issued a Urgent: Medical Device recall notice to affected consignees via sales representative and US Mail. SSS ask consignees to take the following actions: 1. Inform individuals within your organization who need to be aware of this action. 2. Immediately check your internal inventory to locate the affected product. Segregate the affected products, quarantine and discontinue use. 3. Complete the Business Reply Form or use the QR Code on Attachment A. Response is required. a.If you have indicated that product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for products returned upon receipt. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility.
Quantity in Commerce2838 units
DistributionUS Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina , South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Israel and Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NLM
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